Kornimate/medical-research-clean huggingface dataset:
risas procedure in node positive breast cancer following nac

Conditions: Breast Neoplasm; Neoadjuvant Therapy; Axillary Lymph Nodes; Pathological Complete Response

Summary: chemotherapy in clinically node positive breast cancer patients is increasingly administrated in a neoadjuvant setting. the standard treatment regimen in these cases is then: neoadjuvant chemotherapy (nac) followed by breast surgery and an axillary lymph node dissection (alnd). nac results in axillary pathologic complete response (pcr) in 1 out of 3 patients, indicating a complete absence of axillary metastases after completion of nac. in such events, alnd can be regarded as overtreatment that creates unnecessary morbidity. less invasive axillary surgery which can accurately assess axillary pcr is therefore preferred over standard alnd in all patients. in case of detection of remaining axillary lymph node metastases by this less invasive axillary surgical procedure, completion axillary treatment is standard of care. the novel risas procedure is introduced as a possible less invasive axillary staging procedure. risas procedure contains radioactive iodine seed localisation in the axilla in axillary node positive breast cancer combined with a sentinel node procedure. the iodine seed in the axillary lymph node metastasis will be placed prior to start of nac.


Eligibility criteria:
inclusion criteria: * female patient with pathologically confirmed axillary lymph node positive invasive primary breast cancer, treated with neoadjuvant chemotherapy * willing and able to undergo all study procedures. * has personally provided written informed consent. exclusion criteria: * age \< 18 * pregnancy or lactation * contra indications for undergoing iodine seed placement or sentinel lymph node biopsy, such as allergic reaction on iodine, 99m technetium or patent blue. * recurrent breast cancer * previous axillary surgery or radiotherapy * patients with periclavicular lymph node metastases (cn3) * patients with advanced breast cancer (i.e. patients with distant metastases, treated without any furter surgical procedures)
comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on 24-hour blood and ocular perfusion pressures

Conditions: Glaucoma

Summary: this is a data revision with a focus on 24 hour perfusion pressures of data from a previous randomized, double masked, multicenter clinical trial. the aim was to compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (ltfc) on 24-hour mean intraocular pressure (iop) after patients are switched from a nonfixed combination of latanoprost and timolol. the main findings of the original trial had been published on ophthalmology \[2007;114: 2244-2251\].


Eligibility criteria:
inclusion criteria: patients diagnosed as having poag (primary open-angle glaucoma) or ocular hypertension and 18 years or older who fulfilled the eligibility requirements detailed below and signed an informed consent at the screening visit were included. two different groups of patients were potentially eligible: 1. those patients who were controlled (iop\< 21 mmhg) on the nonfixed combination of latanoprost and timolol (twice daily or once daily morning administration) for at least 3 months prior to the baseline visit. 2. patients on monotherapy either with latanoprost or timolol who were eligible for dual therapy being not satisfactorily controlled (iop \< 21 mmhg, or, as judged by the physician, target iop was not reached). pseudoexfoliation glaucomas and patients with diabetes were not excluded. exclusion criteria: all patients in whom beta-blockers were contraindicated were excluded. ocular condition. 1. closed/barely open anterior chamber angles (acas) or history of acute angle closure. the aca was viewed by means of the goldmann 1-mirror lens. shaffer grading was used, and grades ii, iii, and iv were included. grades 0 and i were excluded. 2. ocular surgery or argon laser trabeculoplasty within the last 3 months. 3. ocular inflammation/infection occurring within 3 months before the pretrial visit. 4. neovascular glaucomas. 5. hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions. 6. other abnormal ocular condition or symptom preventing the patient from entering the trial, according to the investigator's judgement. 7. patients on either bimatoprost or the ltfc. 8. patients who had undergone refractive surgery. general 9. inability to adhere to treatment/visit plan. 10. participation in any other clinical trial (i.e., requiring in- formed consent) within 1 month before the prestudy visit. 11. pregnancy, nursing, or, if applicable, nonuse of adequate contraception. 12. any drug known to affect iop.
compensatory reserve index (cri) for management of covid-19

Conditions: COVID

Summary: the fda has approved the cipherox cri t1 tablet for use in subjects aged 19-36, and that this study aims to evaluate the device in subjects aged outside of this range and is being used off label. the fda determined the cipher ox cri t1 tablet to be a class ii device in 2016, and additional research has been done since the fda determination to further support the use of the device outside of its current labeling.


Eligibility criteria:
inclusion criteria: eligible patients will be those who are: * covid-19 positive; * ages \> 18 and \< 70 years old; * require \> 2 liters of oxygen by nasal cannula to maintain spo2 \> 90%; * are admitted to the sixth floor at university hospital, on one of two designated hospitalist services (approximately 16 covid-19 positive patients/service). exclusion criteria: * covid-19 negative * age \ 70 years * on \<2 liters oxygen via nasal canula * pregnant * incarcerated * dnr/dni * decisionally challenged

Keywords: cri compensatory reserve index covid-19 coronavirus
how effective is the dose-graded aerobic training in children survivors of acute lymphoblastic leukemia?

Conditions: Acute Lymphoblastic Leukemia

Summary: the purpose of this study was to evaluate the impact of a 12-week dose-graded aerobic exercise program (d-gae) on cardiopulmonary fitness and physical performance in children survivors of acute lymphoblastic leukemia (all). a total of 58 all survivors were randomly assigned to the d-gae group (n = 29, who underwent a combination of traditional physical rehabilitation and intensity- and duration-graded aerobic training three times per week for 12 weeks) or the control group (n = 29, who underwent only traditional physical rehabilitation). cardiopulmonary fitness and physical performance were evaluated in both groups before and after treatment.

fifty-eight survivors of all were recruited from the hematology-oncology polyclinic at king khalid hospital and two referral pediatric hospitals in riyadh, saudi arabia. the study included survivors aged 10-18 years, who completed maintenance therapy, had no abnormalities of the lower limbs or spine and did not participate in a regular exercise program (in the past six months). survivors who had secondary malignancies, significant musculoskeletal/neurological issues affecting the capacity to participate in exercises or neurocognitive impairments were excluded. outcome measures 1. cardiopulmonary fitness: the peak oxygen uptake was assessed through the mcmaster cycling protocol. 2. physical performance: three tests were used; the 6-minute walk test, the timed up and down stairs test, and the 4x10 meter shuttle run test. interventions the d-gae group received a 12-week aerobic training, three times in addition to the traditional physical rehabilitation. the d-gae program commenced with a training intensity corresponding to 50% of the maximum age-predicted heart rate for 25 minutes in the first two weeks, which progressed on a two-week basis, and ended up with a training intensity corresponding to 75% of the maximum age-predicted heart rate for 50 minutes in the last two weeks. the d-gae program included a warm-up for 5 minutes and a cool-down for 5 minutes. the control group received the traditional physical rehabilitation only, 45 minutes per session, three times a week for 12 consecutive weeks. the program consisted of flexibility exercises, strengthening exercises, balance training, and general conditioning exercises.

Eligibility criteria:
inclusion criteria: * survivors of childhood all * age of 10-18 years * completion of maintenance therapy * free of lower limb or spinal deformities * not participating in regular exercise regimens in the past six months exclusion criteria: * secondary malignancies * significant musculoskeletal/neurological issues * neurocognitive impairments
a study of the effectiveness of xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of the study is to investigate the effectiveness of xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any study-related activities (study-related activities are any procedure related to extraction of data according to the protocol) * male or female patients at least 18 years of age at time of informed consent * diagnosis of t2dm (type 2 diabetes mellitus) * xultophy® initiation prescribed at least 6 months before inclusion in this study (i.e., date of signed informed consent). patients may or may not be continuing xultophy® at study inclusion * minimum available data:a.) at the time of xultophy® prescription: hba1c value (or if unavailable, the most recent hba1c value within 6 months before the first xultophy® prescription);b.) at 6 months plus/minus 45 days after first xultophy® prescription: hba1c value exclusion criteria: * type 1 diabetes * previous participation in this study. participation is defined as having provided informed consent * participation in a clinical trial within 6 months before or 12 months after the first xultophy® prescription (participation in a non-interventional study is not an exclusion criteria) * mental incapacity, unwillingness or inability to provide informed consent, or language barriers precluding adequate understanding or co-operation
health-related quality of life of patients with esophageal cancer after surgery

Conditions: Esophageal Cancer

Summary: the purpose of this multi-center prospective cohort study is to study the health-related quality of life (hrql) together with other outcomes of patients with esophageal cancer after surgery in china.

* to study the influence of health-related quality of life of patients with esophageal cancer before and after surgery. * to compare the impact of different procedures on the the health-related quality of life of patients with esophageal cancer. * to compare morbidities and oncological results(3,5- year survival) from different procedures.

Eligibility criteria:
inclusion criteria: * clinical stage i/ii esophageal cancer * normal blood test of basic metabolism panel * pulmonary function: fev1 \> 1.2l, fev1% \> 50%, dlco \> 50% * heart function: ny grade i and grade ii exclusion criteria: * mental disorders * combination with other cancers * with a previous history of thoracic or ventral surgery

Keywords: health-related quality of life(hrql) esophageal cancer
autologous cell suspension grafting using recell in vitiligo and piebaldism patients

Conditions: Segmental Vitiligo; Piebaldism

Summary: the purpose of this study is to assess the efficacy and safety of recell grafting after co2 laser abrasion with superficial full surface ablation, fractional laser treatment and conventional (deep) full surface co2 laser ablation, to assess the practical aspects and the patient reported outcome and to assess the cellular composition of the graft.

autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating large areas with good cosmetic results. the recell autologous cell harvesting device (avita medical europe limited, cambridge, uk) is a device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. with this device an epidermal cell suspension is created from a split skin graft, usually taken from the hip region. currently, conventional ablative (full surface de-epidermisation) laser treatment in different laser settings is used as pre-treatment to prepare the acceptor site for transplantation. there is no evidence for the laser settings used and no studies are available on the use of a fractional laser as pre-treatment in autologous cell suspension grafting using recell (recell grafting). the investigators hypothesize that more superficial conventional ablative laser treatment and fractional ablative laser treatment are as effective as the current pre-treatment, whereas these treatments are less invasive, provide faster healing and prevent side effects like persisting erythema and scars. furthermore, infiltration anaesthesia is not necessary with these less invasive treatments.

Eligibility criteria:
inclusion criteria: * patients with, segmental vitiligo or piebaldism under medical treatment at the netherlands institute for pigment disorders * age ≥18 * patient is willing and able to give written informed consent * segmental vitiligo stable since 12 months without systemic therapy or 12 months without topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions. * at least four depigmented lesions on the proximal extremities or trunk larger than 3x3 cm or one depigmented lesion on the proximal extremities or trunk of at least 12x3 cm. exclusion criteria: * uv therapy or systemic immunosuppressive treatment during the last 12 months * local treatment of vitiligo during the last 12 months * vitiligo lesions with follicular or non-follicular repigmentations * skin type i * recurrent hsv skin infections * hypertrophic scars * keloid * cardiac insufficiency * patients with a history of hypersensitivity to (uvb or uva) light and/or allergy to local anaesthesia. * patients who are pregnant or breast-feeding * patients not competent to understand what the procedures involves * patients with a personal history of melanoma or non-melanoma skin cancer * patients with atypical nevi. * known allergy to clarithromycin

Keywords: ablative laser fractional laser vitiligo piebaldism cell suspension grafting
effects of estradiol on menopausal breast

Conditions: Hormone Replacement Therapy

Summary: the purpose of this study is to evaluate the effects on breast in postmenopausal women randomized to either oestradiol in combination with drsp or e2 in combination with neta during six months.


Eligibility criteria:
inclusion criteria: * naturally postmenopausal, symptomatic, apparently healthy women, with the need for hormone therapy aged 50 - 70 years with a bmi \>18 and ≤30 kg/m2 and without any previous history of breast disease will be recruited for the study. * they should be amenorrheic for at least 12 months or less than 12 months with s- fsh values \>40 iu/l. * they should be free of any sex hormone treatment for at least three months before inclusion. exclusion criteria: * general contraindications for ht according to swedish product label. age \>60 years. bmi ≤18 or ≥30 kg/m2. * any previous history of cancer. * any previous history of breast disease or abnormal mammogram. * in addition: hypertension (systolic bp \>160 mm hg or diastolic \>100 mm hg), hyperlipidemia (total cholesterol \>8.0 mmol/l or triglycerides \>3.0 mmol/l), diabetes mellitus, history of thromboembolic disease, heart failure, liver disease or porphyria, undiagnosed vaginal bleeding. no sex hormone treatment for at least three months before inclusion. * no concomitant treatment known to influence hormone metabolism (warfarin, rifampicin, carbamazepine, griseofulvin, hydantoins, primidone, barbiturates, broad spectrum antibiotics) is to be accepted.

Keywords: postmenopausal hormone replacement therapy
aneuploidy rates in advanced maternal age patients supplemented with coenzyme q10 (coq10) versus those that are not: a pilot study

Conditions: Mitochondrial DNA; Aneuploidy

Summary: pregnancy rates for women over 35 years old are significantly lower when compared to younger women. one of the causes for this decrease is believed to be chromosomal aneuploidy. chromosomal aneuploidy is a natural phenomena and occurs in women of every age and has been implicated in spontaneous miscarriages, and preimplantation embryo wastage (hassold and hunt, 2001). as maternal age increases, so too does the incidence of chromosomal aneuploidy. embryo quality from older patients undergoing ivf tends to be reduced and associated with higher rates of chromosomal abnormalities when compared to good quality embryos (munne et al., 1995). chromosomal aneuploidy derives from the improper segregation of chromosomes during preimplantation development. the process of segregation, or mitosis, includes synthesis of the complete genome, equal division of chromosomes to opposite poles by the spindle apparatus, and separation of the two cells by cytokinesis, yielding two chromosomally identical cells. the entire process of cellular and genetic replication requires energy in the form of adenosine tri phosphate (atp). atp is mainly produced in mitochondria in the process known as the electron transport chain (etc). there are many important molecules required for atp production, coq10 can act as the appropriate carrier of electrons through the etc. when a deficiency in coq10 is present, atp production is decreased resulting in aneuploidy (bentov et al., 2013). similarly, research has shown that chromosome alignment and spindle formation are affected by mtdna copy number (ge et al., 2012). it has also been shown that the transfer of ooplasm from young, healthy oocyte donors into oocytes of women with repeated embryonic failure has result in children with subsequent mitochondrial heteroplasmy (cohen et al., 1998). coq10 concentrations have been shown to decrease as age increases (bentov et al., 2011). consequently, the decrease in coq10 concentrations seen in older women may cause an increase in chromosomal aneuploidy in subsequent embryos (bentov et al., 2013). in this pilot study, we test the hypothesis that the supplementation of coq10 prior to an ivf cycle can increase mitochondrial dna activity and possibly decrease chromosomal aneuploidy in ama patients.

brief summary

Eligibility criteria:
inclusion criteria: 1. 36-42 years old 2. must present with an amh level ≤2.0 ng/ml 3. 1st cycle of ivf treatment 4. antral follicle count \>5 and \<20 exclusion criteria: 1. bmi \>39 2. active smoker 3. blood serum baseline level of coq10 ≥2.20 µg/ml 4. prior use of coq10 5. type ii diabetes mellitus

Keywords: mtdna aneuploidy ivf blastocyst coq10
efficacy of the bone-anchored hearing aid for unilateral deafness

Conditions: Unilateral Deafness

Summary: the purpose of this 3-year prospective investigation is to examine the short-term and long-term (1 year)efficacy of the bone-anchored hearing aid (baha) in adults with single sided deafness

limited studies have been done on the baha in adults with single sided (sensorineural) deafness, and these studies have evaluated only short-term efficacy at one month post implantation. the findings of the limited number of studies to date on the baha with single sided deafness demonstrate that the baha improves understanding in noisy or group situations and understanding conversation when addressed by a speaker on the side of the bad ear and most users have judged the baha to have at least satisfactory benefit. but conflicting findings have been obtained regarding whether the baha improves the ability to locate the source of a sound. additionally, no studies have been done to see whether the magnitudes of the improvements seen at one month post implantation increase over time because of learning effects or brain plasticity. this investigation will show whether the previously reported baha benefits at one month post baha sound processor fitting, related to speech recognition in noise and subjective satisfaction, persist at one year, and whether learning effects increase the magnitudes of these benefits from one month to one year post baha sound processor fitting. this long-term investigation also attempts to resolve the conflicting findings pertaining to the baha effect on localization abilities. subjects with hearing impairment will comprise 20 adults with single sided deafness who consent to remediation with the baha.in order to see how the adults with unilateral hearing loss will differ from the normal-hearing subjects over time, a control group of 20 normal-hearing individuals also will be evaluated over time, to see how closely the results of the unilateral deafness group approximate the results of the normal individuals.

Eligibility criteria:
inclusion criteria: 1. adult-onset deafness 2. deafness is unilateral - complete or near complete exclusion criteria: 1. the presence of a developmental disorder or mental retardation; 2. history of drug abuse; 3. psychiatric disease; 4. inability to follow instructions or to participate in follow-up appointments 5. inability to use the baha 6. lack of osseo-integration -

Keywords: unilateral hearing loss unilateral deafness bone anchored hearing aid
vitamin d3 for aromatase inhibitor induced arthralgias

Conditions: Breast Cancer

Summary: the primary purpose is to determine if high dose vitamin d3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin d levels.

the primary hypothesis is that high dose vitamin d3 plus standard dose vitamin d3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin d3 treatment. this protocol will examine the relationship between vitamin d levels (25-hydroxyvitamin d) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer. all subjects received letrozole and a standard dose of vitamin d3 (600 iu daily). randomization was between high dose vitamin d3 (30,000 iu once per week) vs. a blinded, matched placebo,

Eligibility criteria:
inclusion criteria: * post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor * serum 25ohd levels \< 40 ng/ml exclusion criteria: * severe or debilitating musculoskeletal pain * known metastatic disease * history of renal stones * history of hypercalcemia or hyperthyroidism * currently receiving adjuvant or neoadjuvant chemotherapy * currently receiving other investigational agents